Resolute Onyx Coronary Stent Systems
FDA premarket approval P160043/S005 · decided 2017-09-01
Approval details
- PMA number
- P160043
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2017-08-04
- Decision date
- 2017-09-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Modify the HPLC method for Zotarolimus active pharmaceutical ingredient (API) testing.
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